The following data is part of a premarket notification filed by Gynetech Pty. Ltd. with the FDA for Manipulator; Manipulator Pro.
| Device ID | K142164 |
| 510k Number | K142164 |
| Device Name: | MANIPULATOR; MANIPULATOR PRO |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | GYNETECH PTY. LTD. 229 MARVILLA CIRCLE Pacifica, CA 94044 |
| Contact | Kevin Macdonald |
| Correspondent | Kevin Macdonald GYNETECH PTY. LTD. 229 MARVILLA CIRCLE Pacifica, CA 94044 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2014-12-17 |
| Summary: | summary |